TYMLOS Drug Patent Profile
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When do Tymlos patents expire, and what generic alternatives are available?
Tymlos is a drug marketed by Radius and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-three patent family members in twenty-eight countries.
The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this compound. Additional details are available on the abaloparatide profile page.
DrugPatentWatch® Generic Entry Outlook for Tymlos
Tymlos was eligible for patent challenges on April 28, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 19, 2025. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for TYMLOS
| International Patents: | 53 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| Patent Applications: | 38 |
| Drug Prices: | Drug price information for TYMLOS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYMLOS |
| What excipients (inactive ingredients) are in TYMLOS? | TYMLOS excipients list |
| DailyMed Link: | TYMLOS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TYMLOS
Generic Entry Date for TYMLOS*:
Constraining patent/regulatory exclusivity:
TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TYMLOS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jacqueline Kernaghan | Phase 4 |
| David Lunardini | Phase 2 |
| Felicia Cosman, MD | Phase 4 |
Pharmacology for TYMLOS
Paragraph IV (Patent) Challenges for TYMLOS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TYMLOS | Subcutaneous Injection | abaloparatide | 3.12 mg/1.56 mL | 208743 | 1 | 2022-06-21 |
US Patents and Regulatory Information for TYMLOS
TYMLOS is protected by twelve US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TYMLOS is ⤷ Sign Up.
This potential generic entry date is based on TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TYMLOS
Abaloparatide formulations and methods of testing, storing, modifying, and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE FOR DETECTING NEUTRALIZING ANTIBODIES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE FOR DETECTING NEUTRALIZING ANTIBODIES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of treating osteoporosis comprising administration of PTHrP analog
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Stable composition comprising a PTHrP analogue
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of drug delivery for bone anabolic protein
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE
Method of drug delivery for bone anabolic protein
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE
FDA Regulatory Exclusivity protecting TYMLOS
INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Exclusivity Expiration: ⤷ Sign Up
TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743-001 | Apr 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743-001 | Apr 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743-001 | Apr 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743-001 | Apr 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TYMLOS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Radius Health Ireland Ltd | Eladynos | abaloparatide | EMEA/H/C/004157 Treatment of osteoporosis. |
Refused | no | no | no | 2019-01-07 | |
| Theramex Ireland Limited | Eladynos | abaloparatide | EMEA/H/C/005928 Treatment of osteoporosis in postmenopausal women at increased risk of fracture. |
Authorised | no | no | no | 2022-12-12 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TYMLOS
See the table below for patents covering TYMLOS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2957278 | ⤷ Sign Up | |
| Brazil | PI0719821 | composiÇço estÁvel na armazenagem apropriada para administraÇço a pacientes e mÉtodo de tratamento de osteoporose nestes | ⤷ Sign Up |
| Japan | 2010505835 | ⤷ Sign Up | |
| Mexico | 2021007056 | MÉTODOS PARA DETECTAR ANTICUERPOS NEUTRALIZADORES DE HORMONA PARATIROIDEA (PTH) Y ANÁLOGO DE PÉPTIDO RELACIONADO CON HORMONA PARATIROIDEA (PTHRP). (METHODS FOR DETECTING NEUTRALIZING ANTIBODIES TO PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE-RELATED PEPTIDE (PTHRP) ANALOG.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYMLOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2073789 | 301235 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213 |
| 2073789 | 2390018-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: ABALOPARATIDE; REG. NO/DATE: EU/1/22/1706 20221213 |
| 2073789 | 23/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 20221213 |
| 2073789 | 2023C/523 | Belgium | ⤷ Sign Up | PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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